Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8183 

applicant claims April 9, 2003, as the 

date the premarket approval application 

(PMA) for S8 OVER–THE–WIRE 

SYSTEM (PMA P030009) was initially 

submitted. However, FDA records 

indicate that PMA P030009 was 

submitted on April 10, 2003. 

3. The date the application was 

approved: October 1, 2003. FDA has 

verified the applicant’s claim that PMA 

P030009 was approved on October 1, 

2003. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 413 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published is incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by April 24, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 22, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: January 25, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3127 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0355] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AMITIZA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

AMITIZA and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the drug product. Although only a 

portion of a regulatory review period 

may count toward the actual amount of 

extension that the Director of Patents 

and Trademarks may award (for 

example, half the testing phase must be 

subtracted, as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product AMITIZA 

(lubiprostone). AMITIZA is indicated 

for the treatment of chronic idiopathic 

constipation in the adult population. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

AMITIZA (U.S. Patent No. 5,284,858) 

from Sucampo AG, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated September 5, 2006, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of AMITIZA 

represented the first permitted 

commercial marketing or use of the 

product. Shortly thereafter, the Patent 

and Trademark Office requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

AMITIZA is 2,197 days. Of this time, 

1,890 days occurred during the testing 

phase of the regulatory review period, 

while 307 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: January 28, 

2000. The applicant claims January 29, 

2000, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was January 28, 2000, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: March 31, 2005. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

AMITIZA (NDA 21–908) was initially 

submitted on March 31, 2005. 

3. The date the application was 

approved: January 31, 2006. FDA has 

verified the applicant’s claim that NDA 

21–908 was approved on January 31, 

2006. 

This determination of the regulatory 

review period establishes the maximum 


cprice-sewell on PROD1PC61 with NOTICES
8184 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,251 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by April 24, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 22, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 3, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3128 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004P–0262] 

Withdrawal of Approval of 128 

Suitability Petitions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 128 suitability petitions. 

This action is being taken in accordance 

with the Pediatric Research Equity Act 

of 2003 (PREA). Prior to PREA’s 

enactment, FDA had approved these 

suitability petitions to permit 

abbreviated new drug applications 

(ANDAs) to be submitted for drugs that 

had a different active ingredient, dosage 

form, or route of administration than 

their reference listed drugs (RLDs). 

However, these approval decisions are 

being withdrawn because ANDAs were 

never submitted and PREA requires that 

all applications submitted on or after 

April 1, 1999, for a new active 

ingredient, new indication, new dosage 

form, new dosing regimen, or new route 

of administration contain an assessment 

of the safety and effectiveness of the 

drug for the claimed indications in 

relevant pediatric subpopulations 

unless the requirement is waived or 

deferred. This action is being taken 

without prejudice. Any of the suitability 

petitions may be resubmitted for action 

by the agency in accordance with 

current law. 

DATES: This notice is effective March 26, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Cecelia M. Parise, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5845. 

SUPPLEMENTARY INFORMATION: PREA 

(Public Law 108–155) was enacted on 

December 3, 2003. Among other things, 

section 2 of PREA requires that all drug 

applications submitted on or after April 

1, 1999, for a new active ingredient, new 

indication, new dosage form, new 

dosing regimen, or new route of 

administration contain an assessment of 

the safety and effectiveness of the drug 

for the claimed indications in relevant 

pediatric subpopulations unless the 

requirement is waived or deferred. As a 

result, FDA is withdrawing its approval 

for 128 suitability petitions for which 

ANDAS were never submitted. The 

approval decisions, made prior to the 

enactment of PREA, would have 

permitted ANDAs to be submitted for 

certain drugs that have a different active 

ingredient, dosage form, or route of 

administration than their RLDs. No 

ANDAs were submitted for these drugs 

pursuant to these suitability petitions 

prior to April 1, 1999, and any such 

application submitted on or after April 

1, 1999, would be required to contain 

the safety and effectiveness assessments 

required by PREA, unless waived or 

deferred. According to § 314.93(e)(1)(i) 

(21 CFR 314.93(e)(1)(i)), a suitability 

petition may not be approved if 

investigations must be conducted to 

show the safety and effectiveness of the 

drug product. In addition, according to 

§ 314.93(f), FDA may withdraw 

approval of a suitability petition if it 

receives information demonstrating that 

the petition no longer satisfies the 

conditions of § 314.93(e). Under PREA, 

safety and effectiveness investigations 

in pediatric subpopulations would be 

required for the drug products proposed 

by these suitability petitions, unless the 

requirement is waived or deferred. 

Therefore, these suitability petitions no 

longer satisfy the regulatory 

requirements for approval. Pursuant to 

§ 314.93(f), FDA is withdrawing 

approval of the 128 suitability petitions 

listed in the following table: 

Petition No. Drug Petitioner 

82N–0032/CP6 Chlorzoxazone 500 milligrams (mg) Mikart, Inc. 

84N–0116/CP1 Disopyramide Phosphate 200 mg or 300 mg Biocraft Laboratories, Inc. 

84P–0228/CP1 Acetaminophen 500 mg, 

Codeine Phosphate 30 mg or 60 mg 

McNeil Pharmaceutical 

85P–0067/CP1 Methyltestosterone 25 mg Star Pharmaceuticals 

85P–0074/CP1 Hydralazine Hydrochloride 25 mg/5 milliliters (mL) Roxane Laboratories, Inc. 

85P–0081/CP1 Flurazepam Hydrochloride 30 mg/mL Do. 

85P–0084/CP1 Vincristine Sulfate 2 mg Bristol Laboratories 


cprice-sewell on PROD1PC61 with NOTICES